What is ISO 3630-3 about?
ISO 3630-3 addresses Endodontic instruments for dentistry purposes and specifies the requirements and test methods for endodontic compactors (pluggers and spreaders) which are used for the compaction of endodontic filling materials, and heat-carriers (which are not specified in the other parts of the ISO 3630 series).
ISO 3630-3 specifies the requirements for size, marking, product designation, safety considerations, and their labelling and packaging.
Who is ISO 3630-3 for?
ISO 3630-3 on endodontic instruments is useful for:
- Dentists
- Manufacturer of Endodontic instruments for dental purposes.
Why should you use ISO 3630-3?
A compactor is an endodontic instrument used manually as a plugger or spreader designed to compact filling materials in the root canal system.
Using ISO 3630-3 guidelines provide minimum requirements and tests methods for endodontic compactors which will improve your manufacturing process and assessment results for endodontic compactors.
ISO 36303 also helps in terms of requirements for size, marking, product designation, safety considerations, and labelling and packaging for endodontic compactors, which will ensure end-user’s and patient’s health and safety.
What’s changed since the last update?
BS EN ISO 3630-3:2021 supersedes ISO 3630-3:2015, which has been withdrawn. BS EN ISO 3630-3:2021 includes some technical changes with respect to ISO 3630-3:2015. These include:
- The symbols D, d3, and d16 in this document have been harmonized with the other parts of the ISO 3630 series
- ‘types’ has been changed to ‘classes’
- Test methods have been improved